Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implants because the inner package labels display incorrect item, lot, and size information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and packaging labeling issue where the correct information is available on the outer package, posing no direct physical hazard or risk of adverse health consequences.
Plain-English summary
Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implant Systems due to labeling errors on the inner package. The inner package labels incorrectly list the item number, lot number, and size, while the outer package labels contain the correct information. The affected products are identified by outer package lot 63781164 and inner package lot 63773888.
The recalled implants were distributed nationwide in the United States and to several international countries, including Australia, Canada, and various European nations. The products are designed for use in the maxilla or mandible to replace missing teeth.
Healthcare providers and patients should verify the lot numbers on their inventory or installed devices against the recall notice. If the inner package labels match the incorrect details provided in the recall, the devices should be removed from use and returned to the manufacturer or an authorized representative.
The recalled product
- Product
- Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or…
- Manufacturer
- Zimmer Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Outer Package Label: LOT: 63781164
- UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164
- Inner Package Label: LOT: 63773888
- UDI: (01) 00889024019508 (17) 220930 (10)63773888.
Distribution
Related recalls
Same manufacturer · Zimmer Dental Inc
See all →- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2018-04-04
- HighZimmer Dental GemLock Hex Driver Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27
- HighZimmer Dental Tapered Screw-Vent Implant Surgical Kits Recalled for Geometry Defect
FDA (Devices) · 2017-12-27
- HighZimmer Dental Surgical Kits Recalled for Manufacturing Defect
FDA (Devices) · 2017-12-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error
FDA (Devices) · 2014-11-05
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implant Lot Due to Labeling Error
FDA (Devices) · 2014-02-05
- ModerateZimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error
FDA (Devices) · 2014-08-13
- ModerateZimmer Dental Recalls Tapered Screw-Vent Implants Due to Mislabeled Lots
FDA (Devices) · 2018-04-04
- ModerateZimmer Dental Tapered Screw-Vent Implant Recalled for Potential Vial Crack
FDA (Devices) · 2014-07-23
- ModerateZimmer Dental Recalls Spline Twist Implants Due to Labeling Error
FDA (Devices) · 2014-11-05